REGULATORY AUTHORITY:

Department of Pharmacy, Drugs and Laboratories, Ministry of Public Health.

CLASSIFICATION SYSTEM

Medical Devices/IVDs (DMDIV): four classes from I to IV.

TIMEFRAME

The official timeline for new product registration is 90 working days.

LICENSE VALIDITY

The registration certificate is valid for 5 years.

LICENSE TRANSFER

License transfer is possible, but no clear procedure (regulation) is currently available.

AUTHORIZED REPRESENTATIVE:

A foreign manufacturer must appoint a local company or a person to become their Authorized Representative.

ADDITIONAL INFORMATION

In practice, not all devices need to be registered. Since there are no pre-established lists, it is necessary to seek the opinion of the DPML based on the specific features of the products to confirm whether registration is required.

Other Sub-Saharan African Countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Central African Republic, Chad, Comoros, Congo, DR Congo, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea – Bissau, Ivory Coast, Kenya, Lesotho, Liberia, Madagascar, Mali, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, South Sudan, Swaziland, Tanzania, Togo, Zanzibar